ROLE OF ROLE OF CONFORMITY ASSESSMENT CONFORMITY ASSESSMENT

IN INDIAIN INDIA

Anil JauhriAnil JauhriAdviserAdviser

Quality Council of IndiaQuality Council of India

INTRODUCTIONINTRODUCTION

Role of Standards & Conformity Role of Standards & Conformity Assessment (CA) procedures important Assessment (CA) procedures important in international trade in WTO regimein international trade in WTO regime

Necessary to lay down rules and Necessary to lay down rules and disciplinesdisciplines

TBT Agreement/SPS Agreement/ TBT Agreement/SPS Agreement/ Agreement on Pre-shipment InspectionAgreement on Pre-shipment Inspection

Adoption of international standards – Adoption of international standards – regulation on grounds of health/safety/ regulation on grounds of health/safety/ environment – market driven voluntary environment – market driven voluntary standards and conformity assessmentstandards and conformity assessment

EMERGING STRUCTUREEMERGING STRUCTUREGovernmentGovernment

(to enact legislation)(to enact legislation)

Regulatory BodiesRegulatory Bodies – may be sector specific like Food, – may be sector specific like Food, DrugsDrugs

(to enforce the law)(to enforce the law)

National Standards BodyNational Standards Body – – Accreditation BodyAccreditation Body (vol. stds-linkage to RBs) - (comp of CABs – link to RBs)(vol. stds-linkage to RBs) - (comp of CABs – link to RBs)

Conformity Assessment Bodies (CABs)Conformity Assessment Bodies (CABs)(voluntary certification/quality assurance (voluntary certification/quality assurance

– – support to regulation)support to regulation)

Manufacturers and Service providersManufacturers and Service providersCommon man – recipient of goods and servicesCommon man – recipient of goods and services

INFRASTRUCTUREINFRASTRUCTURE Standards setting – BIS (NSB), other Standards setting – BIS (NSB), other

voluntary bodies like Agmark – attached voluntary bodies like Agmark – attached to Regulatory Bodiesto Regulatory Bodies

Domestic Regulatory Mechanism Domestic Regulatory Mechanism (BIS/Drugs/PFA) (BIS/Drugs/PFA)

Export regulation/certification system Export regulation/certification system (EIC) for recognition(EIC) for recognition

Conformity assessment bodies Conformity assessment bodies (BIS/EIAs/labs/inspection agencies like (BIS/EIAs/labs/inspection agencies like RITES – govt or pvt))RITES – govt or pvt))

Accreditation Mechanism (QCI/NABL)Accreditation Mechanism (QCI/NABL)

EMERGING INDIAN SCENARIOEMERGING INDIAN SCENARIO

WG on Quality, Certification and Conformity WG on Quality, Certification and Conformity Assessment of Planning Commission Assessment of Planning Commission

Good Regulatory Practice – Unbundling of Good Regulatory Practice – Unbundling of Regulatory Bodies (RBs) from traditional role Regulatory Bodies (RBs) from traditional role of all powerful body - doing everything– clear of all powerful body - doing everything– clear separation between RBs, accreditation separation between RBs, accreditation bodies, conformity assessment bodies and bodies, conformity assessment bodies and promotional bodies – Standards setting and promotional bodies – Standards setting and conformity assessment by technically conformity assessment by technically competent bodies – upgrade to international competent bodies – upgrade to international standards - standards - regulation of CABs to provide regulation of CABs to provide oversightoversight

SUPPORT TO REGULATIONSSUPPORT TO REGULATIONS Conformity assessment essential for effective Conformity assessment essential for effective

regulation of qualityregulation of quality Regulations prescribe conformity assessment Regulations prescribe conformity assessment

procedures including mandatory BIS certification – procedures including mandatory BIS certification – regulation for exports (EIC and others) - Min of regulation for exports (EIC and others) - Min of Agriculture – Inspection of dairy plants for sanitary Agriculture – Inspection of dairy plants for sanitary and hygienic conditions under MMPO by and hygienic conditions under MMPO by independent agenciesindependent agencies

Integrated Food Law – use of NABL accredited labs Integrated Food Law – use of NABL accredited labs –Recognition of agencies for Food safety audits – –Recognition of agencies for Food safety audits – MFPI’s MoU with QCI to provide accreditation MFPI’s MoU with QCI to provide accreditation services for GHP/GMP/HACCPservices for GHP/GMP/HACCP

Ministry of Health – regulation on GHP/GMP/HACCP Ministry of Health – regulation on GHP/GMP/HACCP – draft notification on GHP/GMP already issued – – draft notification on GHP/GMP already issued – compliance checking by accredited agencies compliance checking by accredited agencies

SUPPORT TO REGULATIONSSUPPORT TO REGULATIONS High level committee under Member, Planning High level committee under Member, Planning

Commission – option of 3Commission – option of 3rdrd party certification to party certification to industry to demonstrate regulatory compliance – industry to demonstrate regulatory compliance – Env/OSH/Social Accountability – national/intnl stds Env/OSH/Social Accountability – national/intnl stds – ‘tier 2 certification’ focussed on regulatory – ‘tier 2 certification’ focussed on regulatory compliancecompliance

Regulation of Electronics & IT goods for Safety Regulation of Electronics & IT goods for Safety and EMC – initiative of DIT – under BIS Act - 19 and EMC – initiative of DIT – under BIS Act - 19 products in 1products in 1stst phase – 9 in 2 phase – 9 in 2ndnd phase – Rules of phase – Rules of Compliance being written – provision for Compliance being written – provision for recognizing results of manufacturers’ labs if recognizing results of manufacturers’ labs if accredited or done under supervision of accredited or done under supervision of accredited bodyaccredited body

VOLUNTARY SECTORVOLUNTARY SECTOR

New InitiativesNew Initiatives Certification of service delivery by Public Certification of service delivery by Public

Service Organizations – IS 15700 – Service Organizations – IS 15700 – national programme national programme

Forest certification – MoEF initiating workForest certification – MoEF initiating work Tissue culture production certification – Tissue culture production certification –

national programme initiated by DBTnational programme initiated by DBT Retailer certificationRetailer certification Good SHE Practices in Lead Acid Battery Good SHE Practices in Lead Acid Battery

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CONCERNSCONCERNS Worldwide concern about quality of 3Worldwide concern about quality of 3rdrd party party

certification esp. ISO 9000 – concern in Indiacertification esp. ISO 9000 – concern in India QCI quarterly studies on effectiveness of ISO 9000 QCI quarterly studies on effectiveness of ISO 9000

certifications – CBs ratings on website – voluntary certifications – CBs ratings on website – voluntary programmeprogramme

NABCB exercise of client visits in Mar, 2007 – poor NABCB exercise of client visits in Mar, 2007 – poor quality of certification – 3 CBs under suspension – quality of certification – 3 CBs under suspension – operating with foreign accreditation?operating with foreign accreditation?

Need for greater cooperation between ABsNeed for greater cooperation between ABs National programmes – IS 15700, GHP/GMP – National programmes – IS 15700, GHP/GMP –

freedom to deviate from intnl norms – accreditation freedom to deviate from intnl norms – accreditation system to have safeguardssystem to have safeguards

Feedback – actual user not in loop – mechanism to Feedback – actual user not in loop – mechanism to be devisedbe devised

INFORMATION ON ACCREDITATIONINFORMATION ON ACCREDITATION

QUALITY COUNCIL OF INDIAQUALITY COUNCIL OF INDIA 2nd floor, Institution of Engineers Building2nd floor, Institution of Engineers Building

2, Bahadur Shah Zafar Marg2, Bahadur Shah Zafar MargNEW DELHI - 110002NEW DELHI - 110002

Tel: 011-23379321/9260/0567/8057Tel: 011-23379321/9260/0567/8057Fax: 011-23379621Fax: 011-23379621

email : email : nabcb@qcin.orgnabcb@qcin.org, , info@qcin.orginfo@qcin.orginfo@nabl-india.orginfo@nabl-india.org

Websites : Websites : www.qcin.orgwww.qcin.org www.nabl-india.orgwww.nabl-india.org

Thank youThank you